Hair Transplant Instruments Quality
Scharf Surgical Instruments®
As the team of Scharf hair transplant & Plastic Surgery Instruments Quality since our foundation in 2011, we have always targeted to reach the best quality at reasonable prices. In development and production of our hair transplant instruments, we used the best materials for maximum excellence.
Satisfaction of our customers has always been the most important intention for us. The rapid growth of our company proved that our mission is accomplished. We serve a wide product variety in hair transplant field in best quality and we sell our products worldwide to more than 95 countries.
We keep close track of progress in hair transplant field and we always try to perfectionize our products in light of feedbacks from our customers. We are easily accessible by our customers and in continuous exchange of knowledge and experience with colleagues. We are always open to new ideas that will take us forward.
Our experience, dedication and research over the years are reflected in the highly efficient design and extremely high-quality standard of our products. The expertise of our specialist staff has played an extremely important role in this process. For this reason, we give importance to qualification and training of our staff.
Our Logistics
As the result of our well-organized delivery system, we are able to guarantee fast delivery of orders. Almost all of the items in our extensive product range are stocked and readily available which ensures that they can be delivered quickly. The products always reach our clients via the shortest possible route and the customer’s special wishes can be accommodated. We supply the products within 24-72 hours from Germany office to whole Europe tax and duty free,from United Arab Emirates office to Middle East and from USA office to North America and Canada*.
Close contact with our customers is extremely important to us. For this reason, we exhibit at trade fairs and international hair transplant conferences and workshops all over the world. Our team of engineers and doctors continuously take advice from surgeons in workshops and conferences and improve our quality.
Hair Transplant Instruments Quality Management
Quality Policy: “Scharf FUE Instruments ® is committed to providing our customers with the highest quality products at an exceptional value. We strive for total customer and patient satisfaction by continuously improving our products, processes and Quality Management System”
FDA Approved,
The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
ISO 13485:2004
ISO 13485:2004 specifies requirements for a Plastic Surgery Instruments Quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
ISO 18001:2007 ;
OHSAS 18001:2007 is an internationally recognized assessment specification for occupational health and safety management systems. OSHAS provides a framework that allows the organization to consistently identify and control its health and safety risks, reduce the potential for accidents, aid legislative compliance and improve overall performance
ISO 14001:2004 ;
ISO 14001:2004 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those which it can control and those which it can influence.
ISO 9001:2008 ;
Scharf FUE instruments has implemented a quality management system, which has been certified ISO 9001:2008. It specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements andaims to enhance customer satisfaction through the effective application of the system, including processes for continual improvementof the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
ISO 17664:2017 ;
ISO 17664:2017 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer, so that the medical device can be processed safely and will continue to meet its performance specification.
TSE_HYB ;
Scharf FUE Instruments is certified from Turkish Standards Institution (TSE).
EC Declaration of Conformity. This decleration provides the assurance that products supplied by Scharf Surgical Instruments are in conformity with the essential requirements of the European Medical Devices Directive (93/42/EEC) and are manufactured to the highest standards of craftsmanship in accordance with the relevant
